RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Pembrolizumab for Metastatic Melanoma

Background: Aldesleukin is used to treat metastatic or advanced melanoma and renal cell carcinoma. Pembrolizumab is used to treat many cancers including melanoma.

Official registry: https://clinicaltrials.gov/study/NCT05155033 · National Cancer Institute (NCI) · enrollment listed as 78

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Pembrolizumab, or Aldesleukin. The registry lists allocation as na. Background: Aldesleukin is used to treat metastatic or advanced melanoma and renal cell carcinoma.

They plan to enroll about 78 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma

Interventions: Pembrolizumab, Aldesleukin

Primary outcome (registry wording): Response rate in treatment refractory disease

Who it is for (from inclusion criteria)

Ages 18 Years to 120 Years
Participants must have measurable disease (per RECIST v1.1 criteria), metastatic melanoma or renal cell cancer
Age \>=18 years of age
Clinical performance status of ECOG 0 or 1
Willing to practice birth control from the time of enrollment on this study and for four months after treatment
Must have a negative pregnancy test because of the potentially dangerous effects of the treatment on the fetus
Seronegative for hepatitis B antigen and for hepatitis C antibody. If hepatitis C antibody test is positive, then participant must be tested for the presence of antigen by RT-PCR and be HCV RNA negative
Participants must have adequate organ and marrow function as defined below:

Who the registry excludes

Participant is nursing because of the potentially dangerous effects of the treatment on the fetus or infant
Concurrent systemic steroid therapy
Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses
Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS)
History of major organ autoimmune disease
Grade 3 or 4 major organ irAEs following treatment with anti-PD-1/PD-L1 this drug alone, including but not limited to myocarditis, pneumonitis, colitis, and hepatotoxicity
Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune-competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)

Public study contact (from the registry)

NCI SB Immunotherapy Recruitment Center

(866) 820-4505

irc@nih.gov

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

National Institutes of Health Clinical Center — Bethesda, Maryland (recruiting)

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FAQ about this NCT record

Is NCT05155033 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05155033?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05155033?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary